Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Shionogi B.V., Kingsfordweg 151, 1043GR Amsterdam, Netherlands
Fetcroja is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
It is recommended that Fetcroja should be used to treat patients that have limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases.
Table 1. Recommended dose of Fetcroja1 for patients with a creatinine clearance (CrCL) ≥90 mL/min2:
| Renal function | Dose | Frequency | Duration of treatment |
|---|---|---|---|
| Normal renal function (CrCL ≥90 to <120 mL/min) | 2 g | Every 8 hours | Duration in accordance with the site of infection3 |
| Augmented renal clearance (CrCL ≥120 mL/min) | 2 g | Every 6 hours | Duration in accordance with the site of infection3 |
1 To be used in combination with antibacterial agents active against anaerobic pathogens and/or Gram-positive pathogens when these are known or suspected to be contributing to the infectious process.
2 As calculated using the Cockcroft-Gault formula.
3 e.g. for complicated urinary tract infections including pyelonephritis and complicated intra-abdominal infections the recommended treatment duration is 5 to 10 days. For hospital-acquired pneumonia including ventilator-associated pneumonia the recommended treatment duration is 7 to 14 days. Treatment up to 21 days may be required.
Table 2. Recommended dose of Fetcroja for patients with a CrCl < 90 ml/min1:
| Renal function | Dose | Frequency |
|---|---|---|
| Mild renal impairment (CrCL ≥60 to <90 mL/min) | 2 g | Every 8 hours |
| Moderate renal impairment (CrCL ≥30 to <60 mL/min) | 1.5 g | Every 8 hours |
| Severe renal impairment (CrCL ≥15 to <30 mL/min) | 1 g | Every 8 hours |
| End stage renal disease (CrCL <15 mL/min) | 0.75 g | Every 12 hours |
| Patient with intermittent haemodialysis2 | 0.75 g | Every 12 hours |
1 As calculated using the Cockcroft-Gault formula.
2 As cefiderocol is removed by haemodialysis, administer cefiderocol at the earliest possible time after completion of haemodialysis on haemodialysis days.
No dose adjustment is required in patients with hepatic impairment (see section 5.2).
No dosage adjustment is required (see section 5.2).
The safety and efficacy of Fetcroja in children below 18 years of age has not yet been established. No data are available.
Intravenous use.
Fetcroja is administered by intravenous infusion over 3 hours.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
There is no information on clinical signs and symptoms associated with an overdose of cefiderocol.
In the event of overdose, patients should be monitored and treatment discontinuation and general supportive treatment should be considered.
Approximately 60% of cefiderocol is removed by a 3- to 4-hour haemodialysis session.
Powder: 3 years.
Chemical and physical in-use stability after reconstitution has been demonstrated for 1 hour at 25°C.
From a microbiological point of view, unless the method of opening/reconstitution precludes the risk of microbial contamination, the reconstituted product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and should not be more than 1 hour at 25°C.
Chemical, microbiological and physical in-use stability after dilution has been demonstrated for 6 hours at 25°C and for 24 hours at 2 to 8°C protected from light, followed by 6 hours at 25°C.
From a microbiological point of view, diluted products should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours at 25°C or 24 hours at 2 to 8°C protected from light, followed by 6 hours at 25°C, unless dilution has taken place in controlled and validated aseptic conditions. The 6-hour period at 25°C should be inclusive of the product administration period of 3 hours (see section 4.2). If storing the infusion solution in the refrigerator, the infusion bag should be removed and allowed to reach room temperature prior to use.
For preparation of solution for administration, see Section 6.6.
Store in a refrigerator (2°C-8°C)
Store in the original carton in order to protect from light.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
14 mL vial (Type I clear glass vial), chlorobutyl elastomeric stopper, and aluminum seal with a plastic flip-off cap. The vials are packed in a cardboard carton.
Pack size of 10 vials.
Each vial is for single use only.
The powder should be reconstituted with 10 mL of either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% dextrose injection taken from the 100 mL bags that will be used to prepare the final infusion solution and should be gently shaken to dissolve. The vial(s) should be allowed to stand until the foaming generated on the surface has disappeared (typically within 2 minutes). The final volume of the reconstituted solution in the vial will be approximately 11.2 mL (caution: the reconstituted solution is not for direct injection).
To prepare the required doses, the appropriate volume of reconstituted solution should be withdrawn from the vial according to Table 4. Add the withdrawn volume to the infusion bag containing the remainder of the 100 mL of sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% dextrose injection, inspect the resulting diluted drug product solution in the infusion bag visually for particulate matter and discoloration prior to use. Do not use discoloured solutions or solutions with visible particles.
Table 4. Preparation of cefiderocol doses:
| Cefiderocol dose | Number of 1 g cefiderocol vials to be reconstituted | Volume to withdraw from reconstituted vial(s) | Total volume of cefiderocol solution required for further dilution in at least 100 mL of 0.9% sodium chloride injection or 5% dextrose injection |
|---|---|---|---|
| 2 g | 2 vials | 11.2 mL (entire contents) from both vials | 22.4 mL |
| 1.5 g | 2 vials | 11.2 mL (entire contents) from first vial AND 5.6 mL from second vial | 16.8 mL |
| 1 g | 1 vial | 11.2 mL (entire contents) | 11.2 mL |
| 0.75 g | 1 vial | 8.4 mL | 8.4 mL |
Standard aseptic techniques should be used for solution preparation and administration.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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